A Study to Assess Adverse Events and How Oral ABBV-932 Moves Through the Body When Given With Oral Itraconazole in Adult Participants With Bipolar Disorder

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAbbVie

About this trial

This study will assess the adverse events and how oral ABBV-932 moves through the body when given with oral Itraconazole in adult participants with bipolar disorder.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Body Mass Index (BMI) ≥ 18.0 to ≤ 38.0 kg/m² after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.

A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG

Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) primary diagnosis of bipolar I or II disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0.2).

Disqualifiers

Clinical Global Impression-Severity (CGI-S) > 4 at Screening or Baseline.

History of psychiatric hospitalization (inpatient or intensive outpatient) in the past 3 months prior to screening.

Major depressive or manic episode within the past 3 months prior to screening.

Lifetime history of schizophrenia spectrum or other psychotic disorders, dissociative disorders, or neurocognitive disorders.

Trial design

Design model

Single group

Treatments tested in this trial

  • ABBV-932

    Drug

    Oral Capsule

  • Itraconazole

    Drug

    Oral Capsule

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: ABBV-932 with ItraconazoleExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Maximum Plasma Concentration (Cmax) of ABBV-932 and active metabolites DCAR and DDCAR

Cmax of ABBV-932 and active metabolites DCAR and DDCAR

Time frame
Up to approximately 29 days
2

Time to Cmax (Tmax) of ABBV-932 and active metabolites DCAR and DDCAR

Tmax of ABBV-932 and active metabolites DCAR and DDCAR

Time frame
Up to approximately 29 days
3

Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-932 and active metabolites DCAR and DDCAR

Ctrough of ABBV-932 and active metabolites DCAR and DDCAR

Time frame
Up to approximately 29 days
4

Apparent terminal phase elimination rate constant (β) of ABBV-932 and active metabolites DCAR and DDCAR

(β) of ABBV-932 and active metabolites DCAR and DDCAR

Time frame
Up to approximately 29 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.